REACH-IN - Registration, Evaluation, Authorisation and Restriction of Chemicals

Reach-In webinar

Tools for REACH requirements (latest updated version: September 2017)

A systematic approach to applying REACH requirements to the co-formulants used in Plant Protection Products

REACH legislation, Regulation 1907/2006, brings additional requirements on the use of chemicals across Europe and places a special emphasis on evaluating the safety of their uses to workers, consumers and the environment. This assessment of substances includes co-formulants used in Plant Protection Products. Article 10(a) requires the EU manufacturer or importer to develop a Chemical Safety Report (CSR) which demonstrates that all uses of a substance are safe. Article 37 requires the downstream user to ensure their uses are within the safe use described by the supplier in the e-SDS or take appropriate actions to address this. Please refer to the ECHA Website for further information on company obligations.

ECPA has defined a use map including appropriate use descriptors to describe the Crop Protection uses of co-formulants and developed corresponding tools to be used to assess their safe use for inclusion in the Chemical Safety Report. The use descriptors for the Crop Protection Scenarios are for inclusion in IUCLID and the e-SDS. They are intended for ease of communication up and down the supply chain and are the basis for the contributing exposure scenarios used in the assessment. Based on the used map, ECPA has developed a series of tools which are specifically designed to estimate exposure of workers, consumers and the environment resulting from crop protection uses. (Download the ECPA Guidance Document).

For professional workers (operators) and consumers (amateurs), a specific tool (ECPA OWB v3.3) has been developed. ECPA OWB is a simple to use spreadsheet tool, which provides a more realistic assessment in comparison to the standard REACH tools (ECETOC TRA and CHESAR) as it is specifically designed to assess crop protection uses. In addition, it allows the user to take account of RMMs such as PPE and RPE in the exposure estimation. The output from ECPA OWB is automatically generated in a CSR template format. The ECPA Guidance Document (above) explains how to use the OWB to generate an output for inclusion in the CSR.

To address the regional environmental exposure, the indirect exposure of humans exposed via the environment and secondary poisoning, ECPA has developed Specific Environmental Release Categories (SpERCs). ECPA has also developed CHESAR Import Files (will be updated in the near future, after publication of the new CHESAR version) to enable the use of the SpERCs with CHESAR. A cover letter explains how the ECETOC TRA and CHESAR should be used, in conjunction with the ECPA SpERCs, to generate an output for the CSR.

For the local environmental assessment, a Local Environmental Tool (ECPA LET) has been developed. ECPA LET is a simple to use spreadsheet tool, which provides a local environmental assessment for CP uses which is not covered by the standard REACH tools (ECETOC TRA and CHESAR). The ECPA Guidance Document (above) explains how to use the LET to generate an output for the CSR.

The table below provides a summary of the ECPA recommended approach for the CSR. Further details and explanations are available in the ECPA Guidance Document.

For further information and assistance, please contact christopher.dobe@syngenta.com

For topics related to Safety Data Sheets and the attachment of Exposure Scenarios, please see the CLP FAQs on the classification and labelling page.

 

Exposure assessment

ECPA recommended approach

Professional worker exposure (potential exposure to a co-formulant resulting from PPP use)

ECPA OWB v3.3 (last updated version: November 2015)

Consumer (amateur) exposure (potential exposure to a co-formulant resulting from PPP use)

ECPA OWB v3.3 (last updated version: November 2015)

Indirect exposure of humans via the environment

ECETOC TRA, Chesar or EUSES using ECPA SpERCs (last updated version: September 2017)

Local environmental exposure

- Aquatic freshwater and marine compartments (including secondary poisoning)

- Terrestrial compartment (including secondary poisoning)

ECPA LET (last updated version: January 2017)

(regional concentrations calculated outside LET can be imported)

Regional environmental exposure

- Aquatic freshwater and marine compartments (including secondary poisoning)

- Terrestrial compartment (including secondary compartment)

- Atmospheric compartment

ECETOC TRA, Chesar or EUSES using ECPA SpERCs (last updated version: September 2017)

 

You may be also interested in the publication: Development of REACH Generic Exposure Scenarios for Substances Used as Coformulants in Plant Protection Products

ECPA is making the tools on this webpage available for users to aid them in the assessment of substances used as co-formulants in plant protection products in the context of REACH. The tools have been subjected to thorough testing; however, ECPA does not guarantee that the tools work error-free. ECPA offers no warranty either to the reliability of the tools and the provided information or to the conclusions or assumptions made by any user on the basis of the use of these tools or the use of such information or to the regulatory acceptance of the assessments conducted using the tools. All usage is at the discretion of the user and ECPA is not liable for any consequences resulting from such use.


ECPA is a member of DUCC, an active cross industry forum to exchange on REACH and CLP related matters. The scope of activities is broad but particularly focused on issues related to REACH chemical safety assessment.

Together with other downstream-user associations, ECHA and Members State competent authorities, DUCC has worked to tackle some of the most challenging areas in the implementation of REACH regulation, including sector use mappings, scaling, risk models and standard phrases for hazard. DUCC gives a credible voice to the community of downstream-users under REACH and enables them to work efficiently on downstream-users challenges.

 

 

 

REACH 2018: Are you affected by the deadline?

If you manufacture chemical substances or import them from outside the EU above one tonne per year, you may have registration obligations under REACH. Additionally, if you manufacture or import a product (mixture, article), it may contain substances that need to be registered individually.

If you have pre-registered substances that you manufacture or import from outside the EU above one tonne but not more than 100 tonnes per year and have not already registered them, the REACH registration deadline of 31 May 2018 concerns you.

If you haven't yet pre-registered your substance, late pre-registration may still be an option until 31 May 2017.

Learn more at ECHA’s REACH 2018 page.

 

Supporting documents

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    Cover letter

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    ECPA SpERCs Fact Sheet 2017

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    ECPA Guidance on CSA for Plant Protection Uses under REACH

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    ECPA SpERCs Fact Sheet 2013

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    ECPA CHESAR import

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    OWB v3.3

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    ECPA LET

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